Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
Improvements in early detection and successful treatment of breast cancer have lead to a steady rise in the number of breast cancer (BC) survivors. With so many individuals living for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the implementation of treatment summaries and survivorship care plans (TSSPs) as a mechanism to improve ongoing clinical and coordination of care, and to address the immediate post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial burden of a cancer diagnosis. The need for TSSPs has also been strongly advocated by the American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have been included in the recently introduced Comprehensive Cancer Improvement Act (H.R. 1844). This will be one of the first randomized controlled trials to test the efficacy of TSSPs. The investigators will recruit 500 low income, medically underserved women from two county public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 10-24 months after breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to test the efficacy of TSSPs. The investigators will randomize these women into one of two groups: 1) a control condition of usual medical care and 2) an experimental condition of the control condition + a tailored TSSP + 1 face-to-face nurse counseling session, with all cancer specialists and primary care physicians of record also receiving the TSSP and a cover letter suggesting how they can be clinically utilized. The investigators specific aims are to assess and compare between experimental and control groups the following primary outcomes at one year post-intervention: 1) discussion and implementation of recommended breast cancer survivorship care, including surveillance and the evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with survivorship communication and care, 3) pertinent aspects of health-related quality of life, and further, to then 4) assess the cost-consequences of the experimental intervention. This study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income, underserved population of BC survivors known to be at high risk for poorer long-term outcomes, including in mental health, quality of life, recurrence and mortality, and will therefore allow us to demonstrate the greatest possible benefit of such an intervention.
Key facts
- Study ID
- NCT01627366
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 500
- Starts
- 2012-08-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2016-08-01
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- 21 years of age or older
- English- or Spanish-speaking
- Diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or III BC for the first time
- 10-24 months post-diagnosis
- At least 1 month post-chemotherapy completion
You may not qualify if…
- Previous cancer except non-melanomatous skin cancers or in situ non-breast cancers
- Pregnant and lactating women
- Patients receiving parenteral anti-cancer therapy, except trastuzumab
- Clinically apparent cognitive or psychiatric impairment
- Participation in another research study
- Current treatment for another cancer
- Male
- Residing outside of Los Angeles County
- Too ill to participate
Where it is running
- UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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